The Importance of Material Tracing

Traceability on a processing or production line is incredibly important, especially when it comes to food products, where having the ability to track every ingredient down to the source is crucial to the health and safety of the consumers.

As parts of the country begin to move out of COVID-19 shutdowns, we have been hearing about “contact tracing” as a tool for containing a secondary spread of the disease. Material, lot tracing, or traceability has been part of producing safe food products for a long time. The concepts behind contact tracing and material tracing are similar.

The US food industry should be rightfully proud and the US consumer properly thankful that behind the scenes, out of sight and out of mind, tremendous efforts are being made to ensure food safety.

The Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs) require “traceability to the source.” Establishing traceability to the source for all intended and unintended ingredients of a product in a consumer’s grocery cart relies on each producer or manufacturer that contributed to that product to have and be able to rapidly retrieve traceability data for its products.

To enable tracing, food ingredients and final products are produced and packaged in “lots.” For example, a lot may be the amount of product produced by a certain producer on a certain line during a certain day. Each producer tracks the lot numbers of any ingredients that are used in the production of any final product lots.

Confused? Let’s investigate that bottle of salad dressing you picked up the other day. That bottle has a lot code on the label. The dressing manufacturer can use that lot code to pull up a list of the ingredients, the producer of the ingredients and the producer’s lot codes for the exact ingredients that went into that bottle. A bottle of salad dressing may have 10-15 ingredients. Those ingredients may have ingredients. Each producer down the line—all the way back to the source—can do the same. That is “traceability to the source.”

If you are thinking, “Wow, that’s a lot of data unlocked by one number on my dressing bottle label that I never noticed before,” you are exactly right. If you are thinking, “Wow, how would we ever collect and manage data for contact tracing and who would responsibly manage that data,” you are also right. But try, if you can, to refocus on food material tracing.

The data each producer must collect, store, and be able to retrieve can be gathered manually, semi-automatically, or automatically. It can be stored in boxes of paper or in a relational database. Incomplete or inaccurate data can create tremendous liability. Activities required to collect, store, and retrieve data add to cost-of-production, so it needs to be performed efficiently. Across the industry, there are a myriad of tools and methods for collecting, storing, and retrieving traceability data accurately and efficiently.

When building new or performing a significant upgrade to an existing production line or process cell, collection and storage activities can be tightly integrated into the operating controls for maximum accuracy, minimal cost, and minimal operator interference. The system can integrate fully with the plant’s ecosystem including inventory databases that contain manufacturer and lot information. Collected information is stored with batch records to be easily retrieved with off-the-shelf reporting tools. Operator interaction might involve some barcode scanning and/or verification. Automated weighing and dispensing increase the level of integration possible.

Often older systems utilize paper forms or forms on a computer screen. Essentially manual systems are prone to human inaccuracy and consume valuable operator time. Such systems were or are less expensive to implement but are often not less expensive over the project lifecycle.

When a targeted upgrade is done to a line or process cell, collection activities are often semi-automatic. A semi-automated system interacts with the operators by providing clear instructions for activities that need to be performed, such as specifying where to locate containers from the appropriate ingredient lot. All activities are electronically journaled, including amounts of ingredients consumed, either automatically or by operator entry. Instructions can be provided for intermediate materials, such as kits, as well as for finished products. Semi-automated systems can also interact with the plant ecosystem, such as the enterprise resource planning system, to receive work orders, execute them and report material consumed and finished goods produced.

Traceability, whether food ingredient tracing or contact tracing, is incredibly important for the health of people living in our communities and nation. Tracing food product ingredients to the source requires detailed collection, storage, and retrieval of accurate and complete data. Producers that accomplish this accurately and efficiently have a competitive advantage. How are you handling traceability? How can you reduce costs and increase accuracy?

This is a re-post of a July 2020 Automation World blog. To see the original piece, click HERE.

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Properly Using A Recipe Lifecycle Management System

*This blog has been re-published from Automation World! You can see the original published work here.

 

Protecting the sanctity of a product is an important aspect of recipe lifecycle management, but the flexibility of your system may not be fully utilized. See how a system can easily be extended to a new product without much change when properly installed.

ISA-88 batch recipes are not just simple lists of ingredients, they describe the ordered process for producing a product. Recipes make your system flexible enough to produce multiple products and agile enough to make quick yet safe changes. Recipe lifecycle management is important to batch manufacturers because the recipes represent a significant portion of the system programming.

A proper batch manufacturing system separates the programming that supports the capabilities of the system’s equipment from the programming that defines what the manufacturer wants to do with the equipment. Equipment programming runs a pump after making sure there is a clear flow path. This programming—which is concerned to safely operate the pump independent of what is being pumped—is often in a programmable logic controller or a programmable automation controller. Procedure programming instructs the pump to run at the appropriate point in the manufacturing process, this programming—which is concerned to effectively produce high quality products—is the programming in your batch recipe.

Why this separation? The programming that supports what the equipment is capable of never changes—that is unless the equipment is changed or the programming was incompletely developed in the first place. What a manufacturer does with that equipment can change dramatically.

So, how might a manufacturer today use a line originally designed to make pancake syrup changeover to produce hand sanitizer needed to protect the world from COVID-19? If this fundamental concept was followed, all that would need to be done is to write a new recipe and, of course, put the corresponding ingredients into the supply tanks! And, if done correctly any process-knowledgeable person, capable of manipulating flowcharts, can make these changes without inadvertently modifying or bypassing equipment programming designed to prevent equipment damage or misuse and without engaging outside resources.

Your recipes are valuable! They encapsulate your intellectual property and the best practices for making your products. They are a significant part of your system, orchestrating the steps your equipment needs to make your products. Any change made to your recipes may improve or degrade the quality of your products or the effectiveness with which they are manufactured.

This is but one reason why properly implemented, world-class batch manufacturing systems utilize a proven recipe lifecycle management package with recipe lifecycle management tools—such as security, genealogy tracking, version management, enforced approval requirements and audit trails. One such market-leading package is Rockwell Automation’s FactoryTalk Batch.

Capable recipe lifecycle management should include security controlling which limits who can edit your master recipes. It should support the coexistence of multiple recipe versions, with only one holding the “released to manufacturing” status. Individuals deemed trustworthy to develop and modify recipes need to be able to create separate versions for testing ingredient changes or other process improvements. The genealogy of these derivative recipes—which version of which prior recipe this version was created from—should be tracked as it helps developers keep track of what they have done. Version management also allows a developer to release an improvement for manufacturing, evaluate its effects on the product and on the product’s effective production, then roll back to the previous version if necessary. Enforced approval requirements facilitate communication between developers and production managers, assuring all stakeholders buy into any modifications. Audit trails help teams figure out what happened if something does go wrong.

These may sound familiar if you are familiar with GAMP 5. Originally developed by ISPE for the pharmaceutical industries, GAMP 5 is being adopted by many food and beverage manufacturers seeking a risk-managed approach to more consistent production practices and improved food safety.

Does your manufacturing system include a capable batch management product? Are you using it? Are you using all its capabilities? Is your programming properly divided so that your recipes can manage all your equipment capabilities? Any or all of these might be opportunities to improve your operations. Perhaps now is a good time to get started.

 

 

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The Benefits of Off-The-Shelf SOP Management Software

Being able to keep track of every step and every bit of data is a major necessity for every organization. An off-the-shelf standard operating procedure software is one way to implement new processes and keep track of business operating standards.

Tracking manual operations in discrete, batch, and continuous manufacturing processes can greatly benefit from off-the-shelf products. Clearly specifying your procedures, enforcing their execution, and capturing pertinent data are all major benefits that can be quickly and easily be obtained by implementing off-the-shelf, procedure management software.

To ensure consistency, manufacturers use Standard Operating Procedures (SOPs) to specify how operations are to be done. SOPs may be developed for product operations, safety, periodic maintenance, startup or shutdown operations.

Often, discrete manufacturing processes require a high level of manual operator activities that rely on paper-based SOPs to specify how to manufacture their products.

It is the responsibility of employees to perform the tasks specified in the SOP and to capture any required data. Even in relatively automated process control systems, it is not uncommon to find SOPs that require an operator to input the setpoints or record readings before initiating the required tasks. Sometimes data is recorded on the SOP or a related paper form, but, oftentimes the date and employee identification is required.

As the volume of amount of data and the value of accuracy increases, as does the justification for automating the SOP and data collection.

Standard, off-the-shelf products can be used to replace the paper-based SOPs and electronically interface with the operators via portable devices such as phones, iPads, industrial portable terminals, etc. One such product is Rockwell Automation’s FactoryTalk Batch.

The unfortunate name of the product implies that it is only helpful with batch manufacturing processes, but, in fact, it is very helpful automating any operation where following an ordered set of steps and collecting data is required. FactoryTalk Batch is really a sequencing engine that follows the steps of an operating procedure or recipe.

The operating procedures are clearly specified electronically. A sequencing engine is responsible for prompting the operator to perform the tasks in the order specified by the electronic SOP. Off-the-shelf sequencing engines contain features that streamline the process of following the SOP and recording required data. Many sequencing engines, including FactoryTalk Batch, can transfer required set points to the process control system as well as directly capture process information without relying on the operators. In partially automated processes, data collected from operators via electronic forms can be merged with automatically collected data.

The sequencing engine is now the orchestrator of the process activities and is responsible for interacting with the operator, to instruct them to perform manual tasks and capturing information not available electronically; at the same time, it coordinates all activities with the equipment it can interact with.

This off-the-shelf sequencing engine can be interfaced with the enterprise-resource planning system in order to receive production orders, it clearly specifies and maintains SOPs and their versioning, it coordinates all manual and automated procedural activities, and it captures all pertinent information to recall how a product was made including material traceability.

Fixed industrial human-machine interface products or mobile devices can be used for operator interaction.

Clients see return through increased product yields and improved overall equipment effectiveness. An ISO-9001 certified client realized tremendous benefit in reduced labor costs. Being able to use an off-the-shelf package, significantly reduces implementation cost and schedule. Perhaps you can benefit too.

This is a re-post from a March 2020 Automation World blog. To see the original post, click HERE.

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